FDA 483 - Dental Technologies Inc.

Dental Technologies, Inc. received a Form 483 citing multiple deficiencies across its manufacturing and quality control operations. Key issues include inadequate sampling plans, deficient microbiological testing methods, and failures in investigating discrepancies and out-of-specification results. The firm also demonstrated shortcomings in cleaning validation, documentation practices, corrective and preventive actions, design validation, and risk analysis for both drug products and medical devices.